Good Manufacturing Practice (GMP) is a
system to ensure products are consistently produced and controlled according to
quality standards.
The “c” in cGMP stands for current
which indicates that the most recent standards, technology, and methods are
being applied to operations.
The terms are largely interchangeable, with one major difference. The use of the term cGMP implies a commitment to the highest available standards of quality which is why it is important to make the distinction in a competitive and rapidly adapting market.
Which standards to choose?
As international regulatory regimes develop, so do barriers to trade as countries try to establish independent standards by which they regulate cannabis products. In order to penetrate the highest value markets, companies must be able to meet global standards for production, quality management and analysis.
Currently, the emerging EU cannabis market has led many firms to adopt EU-cGMP and ISO standards of quality. Mutual recognition agreements (MRA) for pharmaceutical cGMP between the EU and several other developed nations allow market access to international companies demonstrating adherence to these guidelines. So, which are the relevant standards and to what do they apply?
EU-cGMP: Good Manufacturing Practices
for pharmaceutical products
EU-cGMP provides a comprehensive structure for quality management, production and safety for pharmaceutical operations. This guideline enforces similar requirements to the WHO cGMP and FDA cGMP making it a strong reference for companies targeting international markets.
ISO/IEC 17025; 2017: General
requirements for the competence of testing and calibration laboratories
2017 guidelines are the benchmark for international laboratories by which they demonstrate technical competence. Laboratory customers, regulatory authorities, organizations and schemes using peer-assessment, accreditation bodies, and others, use this document in confirming or recognizing the competence of laboratories.
ISO/IEC 31000; 2018: Risk Management
2018 guidelines provide principles, framework and a process for managing risk. It can be used by any organization regardless of its size, activity or sector. Regulatory agencies have transitioned to a risk management-based approach to quality standards. As a result, companies that adopt ISO/IEC 31000: 2018 guidelines have a greater ability to navigate audits and mitigate risk factors that affect their bottom line.
Outlook
Jurisdictional differences in regulations will continue to be a challenge for international cannabis companies, however, these challenges can be successfully managed though the adoption of recognized standards as an industry. By building confidence that the cannabis sector can operate on the level of the pharmaceutical industry in terms of quality standards, MRAs and consumer demand will allow ease of movement through international markets. Companies that choose to adopt internationally recognized standards of quality will have the ability to establish a foothold in the global cannabis market. Those that do not will face mounting challenges in the face of an extremely competitive, fast moving industry and an increased burden of compliance as jurisdictional regulations struggle to catch up to global standards.
References
WHO good manufacturing practices for pharmaceutical products: Main principles1 (Ser. 961, pp. 1-60, Tech. No. 48). (2014). WHO Expert Committee on Specifications for Pharmaceutical Preparations. doi:https://www.who.int/medicines/areas/quality_safety/quality_assurance/TRS986annex2.pdf?ua=1
The rules governing medicinal products in the European Union (Vol. 4, Rep.). (2013). Brussels: EUROPEAN COMMISSION HEALTH AND CONSUMERS DIRECTORATE-GENERAL.
A Risk Practitioners Guide to ISO 31000: 2018 (Vol. 3, pp. 1-20, Tech.). (2018). London: Institute of Risk Management. doi:https://www.theirm.org/media/3513119/IRM-Report-ISO-31000-2018-v3.pdf
Anonymous. (2019, July 16). Mutual recognition agreements (MRA). Retrieved from https://www.ema.europa.eu/en/human-regulatory/research-development/compliance/good-manufacturing-practice/mutual-recognition-agreements-mra
By Bryan Goldner, Regulatory Manager – LATAM, TheraCann International.
